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Transphyseal Vs. Physeal Sparing ACL Reconstruction in Skeletally Immature Patients: Risk of Subsequent Lower Extremity Growth Deformity

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ClinicalTrials.gov Identifier: NCT03081026
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Duke University

Brief Summary:
To assess the risk of lower extremity angular growth deformity following anterior cruciate ligament (ACL) reconstructions in young patients who are not yet skeletally mature. The study will compare two surgical techniques (physeal sparing vs transphyseal).

Condition or disease Intervention/treatment
ACL Reconstruction Diagnostic Test: Bilateral hip to ankle x-ray, exam and strength testing.

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Transphyseal Vs. Physeal Sparing ACL Reconstruction in Skeletally Immature Patients: Risk of Subsequent Lower Extremity Growth Deformity
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Group/Cohort Intervention/treatment
Ages less than 12
Those having ACL Reconstruction surgery during the desired dates at age 12 or less.d
Diagnostic Test: Bilateral hip to ankle x-ray, exam and strength testing.
Only an X-Ray is performed and reviewed to identify any growth disturbances.

Ages 12-13
Those having ACL Reconstruction surgery during the desired dates at ages 12 and 13.
Diagnostic Test: Bilateral hip to ankle x-ray, exam and strength testing.
Only an X-Ray is performed and reviewed to identify any growth disturbances.

Ages 14 - 16
Those having ACL Reconstruction surgery during the desired dates at ages 14 - 16.
Diagnostic Test: Bilateral hip to ankle x-ray, exam and strength testing.
Only an X-Ray is performed and reviewed to identify any growth disturbances.




Primary Outcome Measures :
  1. Limb length discrepancy [ Time Frame: Clinic visit, approximately 1 hour ]
    Bilateral hip to ankle radiographs measurements.

  2. Limb Angular alignment [ Time Frame: Clinic visit, approximately 1 hour ]
    Bilateral hip to ankle radiographs measurements


Secondary Outcome Measures :
  1. Range of motion measurements [ Time Frame: Clinic visit, approximately 1 hour ]
    Each patient will be examined and measures of knee range of motion with a goniometer, Lachman and pivot shift will be performed. The Lachman and pivot shift will be dichotomized into two groups: normal/nearly normal and abnormal/severely abnormal.


Other Outcome Measures:
  1. Patient Reported Outcomes surveys [ Time Frame: Clinic visit, approximately 1 hour ]
    Pedi IKDC and level of activity/sports participation (UCLA Activity Score) after the initial recovery period.



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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Single site patients of five orthopaedic sports medicine attendings who had an ACL reconstruction between the ages of 6-16 with open physes in the time interval from January 1, 2005-December 31, 2016.
Criteria

Inclusion Criteria:

  • Subjects will be identified by reviewing medical records that include a procedure code for ACL reconstruction in patients between the ages of 6-16 at the time of surgery. Patients meeting the inclusion criteria will be contacted by phone and invited to participate in the study. A key personnel member who is part of the principal investigator's research staff will make phone contact with the patient. The study will be explained and any questions that the subject may have will be answered at that time. If the subject agrees to participate in the study, he/she will make an appointment at that time to come in to be consented and participate in the study and for imaging and testing at Duke Sports Sciences Institute.

Exclusion Criteria:

  • Pregnant Females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081026


Contacts
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Contact: Suzanne Finley 919-684-5431 suzanne.finley@duke.edu
Contact: Elizabeth Pennington, RN 919-684-6071 elizabeth.pennington@duke.edu

Locations
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United States, North Carolina
Duke Sports Science Institute Recruiting
Durham, North Carolina, United States, 27705
Contact: Suzanne Finley       suzanne.finley@duke.edu   
Contact: Libby Pennington, RN       elizabeth.pennington@duke.edu   
Principal Investigator: Dean Taylor, MD         
Sponsors and Collaborators
Duke University
Smith & Nephew, Inc.
Investigators
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Principal Investigator: Dean C Taylor, MD Duke Sports Medicine

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03081026     History of Changes
Other Study ID Numbers: Pro00063612
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified data will be sent to SmithNephew

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
surgery
ages 6-16